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October 2021

Post Script: a further critique of currant trials methodology - Implications for research into orthodox and complementary therapies

Journal/Book: Complementary Medical Research. 1986; 1: 48-54.

Abstract: The search for suitable methods for testing the efficacy of complementary medical treatment has stimulated novel and constructive approaches and exposed weaknesses in both the assumptions and the methodology of current practice. In particular, Heron (1985 pers. comm.), and p. 12 this volume, has pointed out that individuals vary in the way in which malfunction (illness) is experienced in the progress of the illness and of the underlying disease, and in their response to treatment. In each respect this is borne out by medical experience, most explicitly perhaps in the frequency of unwanted drug reactions. Heron argues that the validity of the randomized trial rests on an assumption of homogeneity of subjects which cannot be met, and that even when valid, the relevance of results is open to question because important, potentially interacting variables are controlled out in the trial design. These criticisms are justified and point to the need for modifications both in trial design and in analytic method.Any modification of design must guard against both observer bias and all forms of ´choice' bias, and against spurious findings due to chance, and must offer ways of distinguishing treatment effects from placebo effects and from spontaneous changes in disease activity. The methods evolved must be able to be applied with as much rigour and discipline as the better randomized trials.

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